Dermfree Original Nasal

Description

Naphazoline HCl is a pharmaceutical compound utilized for its vasoconstrictive properties. The chemical name of the active ingredient is Naphazoline hydrochloride. Specific physical characteristics and details regarding inactive ingredients are not provided. Further information regarding its molecular weight and chemical formula is also not included in the available data.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with colds, hay fever, or other upper respiratory allergies. Additionally, it provides temporary relief from sinus congestion and pressure.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older, under adult supervision, are instructed to administer 2 or 3 sprays in each nostril. Dosing should not occur more frequently than every 10 to 12 hours, and the total number of doses should not exceed 2 in a 24-hour period. For children aged 6 to under 12 years, consultation with a healthcare professional is recommended prior to use. This product is contraindicated in children under 6 years of age.

Prior to administration, the bottle must be shaken well. For first-time use, the protective cap should be removed, and any safety clip from the tip should be discarded. The metered pump should be primed by firmly depressing it several times.

To administer the spray, the healthcare professional should instruct the patient to hold the bottle with the thumb at the base and the nozzle positioned between the first and second fingers. The nozzle should be inserted into the nostril without tilting the head. The pump must be fully depressed with a firm, even stroke while the patient sniffs deeply. After use, the nozzle should be wiped clean to maintain hygiene.

Contraindications

Use is contraindicated in children under 6 years of age.

The product should not be used in the presence of nasal congestion, as this may exacerbate symptoms. Frequent or prolonged use may lead to a recurrence or worsening of nasal congestion. Additionally, the use of this container by more than one person may increase the risk of spreading infection.

Warnings and Precautions

Patients should not use this product if they have a known allergy to any of its ingredients. Prior to use, it is essential for individuals with a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland to consult a healthcare professional.

During the use of this product, it is critical to adhere to the recommended dosage. Users are advised to discontinue use after three consecutive days and take a break for one day before resuming as directed. This product should not be used in the absence of nasal congestion, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion. Users may experience temporary discomfort, including burning, stinging, sneezing, or increased nasal discharge. Additionally, sharing this container with others may pose a risk of spreading infection.

Patients should stop using the product and consult a healthcare provider if symptoms persist. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may occur in individuals who are allergic to any of the ingredients. It is advised that patients consult a healthcare professional prior to use if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

Common adverse reactions reported during use include temporary discomfort, which may manifest as burning, stinging, sneezing, or increased nasal discharge. These reactions are generally mild and transient. Patients are cautioned against exceeding the recommended dosage, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion. It is recommended that after three consecutive days of use, patients should discontinue use for one day, adhering strictly to the provided instructions.

In addition, it is important to note that the use of this product by more than one person may facilitate the spread of infection. Patients should stop using the product and consult a doctor if symptoms persist.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Dermfree Original Nasal (naphazoline hcl 0.05% original nasal). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should not use this medication. For children aged 6 to under 12 years, it is advised to consult a doctor before use.

For adolescents and adults aged 12 years and older, the recommended dosage is 2 or 3 sprays in each nostril, not to be administered more frequently than every 10 to 12 hours. The maximum allowable dosage is 2 doses within a 24-hour period.

If symptoms persist, it is important to discontinue use and seek medical advice. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There are no specific warnings, precautions, or dosage modifications associated with the use of DERMFREE ORIGINAL NASAL (naphazoline hcl 0.05%) during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnant patients or if there are any known risks to fetal outcomes. As such, healthcare professionals should consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy. It is recommended that the benefits and potential risks be carefully weighed before administration.

Lactation

There are no specific warnings or recommendations regarding the use of DERMFREE ORIGINAL NASAL (naphazoline hcl 0.05%) in lactating mothers. The insert does not provide information on the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, monitoring, or precautions. As such, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, given the absence of detailed guidance on its use in this population. Regular monitoring of renal function may be advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

Exceeding the recommended dosage of the medication is strongly discouraged. Healthcare professionals should advise patients to adhere strictly to the prescribed dosage guidelines to avoid potential complications associated with overdosage.

In cases where the medication has been used continuously for three days, it is imperative to instruct patients to discontinue use for one day. This practice is essential to mitigate the risk of adverse effects and to ensure the medication remains effective. Patients should be reminded to use the medication only as directed and specifically when nasal congestion is present.

It is important to note that frequent or prolonged use of the medication may lead to a recurrence or worsening of nasal congestion. Therefore, healthcare providers should monitor patients for signs of overuse and educate them on the importance of following the recommended usage instructions to prevent complications associated with overdosage.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience has indicated that the use of DERMFREE ORIGINAL NASAL may result in temporary discomfort, which can include symptoms such as burning, stinging, sneezing, or increased nasal discharge. Additionally, frequent or prolonged use of the product may lead to a recurrence or worsening of nasal congestion. It has also been reported that using this container by more than one individual may facilitate the spread of infection.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center if the medication is swallowed. It is important to inform patients that this medication is not recommended for use in children under 6 years of age.

Patients should be instructed to stop using the medication and consult a doctor if their symptoms persist. When using the medication, patients should be made aware that after continuous use for 3 days, they should discontinue use for 1 day, and they should only use the medication as directed. It is crucial to emphasize that the medication should not be used in the absence of nasal congestion, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion. Patients may experience temporary discomfort, including burning, stinging, sneezing, or increased nasal discharge.

Additionally, healthcare providers should recommend that patients avoid sharing the container with others, as this may facilitate the spread of infection. For children aged 6 to under 12 years, patients should be advised to consult a doctor before use.

Storage and Handling

The product is supplied in packaging that includes relevant NDC numbers. It is essential to store the product at a temperature not exceeding 25°C to maintain its integrity and efficacy. Healthcare professionals are advised to retain the box for future reference to the full labeling information, which may be necessary for proper handling and administration.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Dermfree Original Nasal, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)